Had been visiting Organic popup markets around Mumbai recently to understand the ecosystem.
Was shocked when I came to know that it took one entrepreneur almost 15 months to get an FDA License for his handmade soap production unit in Mumbai.
Wanted to know Rodinhooders, is it the same in every state?
Can anyone share their experiences? Or the experiences of anybody you know has started a business in this field?
Would love to hear your thoughts..
Puneet Nirogam Aggarwal
Hi Saptarshi,
Which FDA license are you talking about ? USFDA or Maharashtra FDA ?
Would FDA license even apply to a soap ? Soap is a topical product ? Does the Soap claim any thing like a drug. So if it does not claim anything, then neither would it be a food, not a drug, so why would they need to apply for a license from a Food and Drug Administration ?
As per my knowledge, the handmade soap willl come under Drug and Cosmetics Act under Schedule M-II.
Let me know if I am missing something here.
Saptarshi Baksi
Hi Puneet,
Thanks for your reply.
I checked my notes.. Thats the license I was also told about – Schedule M-II of the Drugs and Cosmetics Act. Thats the license which took him 15 months to obtain. And from what I understood its the local FDA authority who issues the license.
Ishween of Nyassa also talks about the FDA licenses required in this article here.
But the entrepreneur I met told me that the FDA authorities give the licenses based on the manufacturing facilities confirming to their requirements:
1. A minimum of 1000 sq ft area.
2. Should be in an industrial zone away from city etc..
I was talking to a friend from the US and there they don’t have laws that need you to have a unit away from residential areas and stuff. You can make them at home, sell them online, in retail and you just need to take care that you label them correctly. There are some words like healing,curing etc etc which you can’t use because these products won’t be lab tested.
What are your insights Puneet? And if its the Schedule M-II license required then how much time should it take to obtain it once you have the manufacturing unit according to their requirements?
Puneet Nirogam Aggarwal
Saptarshi,
If its a cosmetics license that is Schedule M-II, do you think it has to be issued by FDA ? I doubt. Here are the guidelines posted here. I suppose you also need to have a chemist onboard your team before you can apply for the license.
If you are planning to do this on a smaller scale, then you should approach KVIC office in your state. (https://www.kvic.org.in/kvicres/index.html). They might have certain exceptions for Micro/Small enterprises.
You would need to read up on it.